MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71702-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Unspecified Infection (1930); Swelling (2091)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A healthcare provider, calling on behalf of the customer, reported that the customer experienced an allergic reaction after a day of wearing an adc freestyle libre sensor, although the caller noted that the customer has used the freestyle libre system for more than 2 years.Customer experienced symptoms described as severe swelling and abscess.Customer had contact with a dermatologist who prescribed an unspecified "strong" antibiotic therapy and skin tac (barrier wipe) for treatment.There was no report of death or permanent injury associated with this event.

Event Description

A healthcare provider, calling on behalf of the customer, reported that the customer experienced an allergic reaction after a day of wearing an adc freestyle libre sensor, although the caller noted that the customer has used the freestyle libre system for more than 2 years.Customer experienced symptoms described as severe swelling and abscess.Customer had contact with a dermatologist who prescribed an unspecified "strong" antibiotic therapy and skin tac (barrier wipe) for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product was returned, and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for all libre sensors and libre sensor kits were reviewed within expiration at the time of the complaint, and the dhr review showed no there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.Clinical data was reviewed, representative of product available in the field, and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was performed for the reported complaint and libre sensors, the investigation showed no anomalies or non-conformances that could lead to the complaint.If the product is returned, the case will be re-opened and a physical investigation will be performed.

• Brand Name: FREESTYLE LIBRE
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8071082
• MDR Text Key: 127146326
• Report Number: 2954323-2018-08656
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention